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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·
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`·1· · · · · · IN THE UNITED STATES DISTRICT COURT
`· · · · · · · · ·FOR THE DISTRICT OF DELAWARE
`·2· ·- - - - - - - - - - - - - - -x
`· · ·PFIZER INC. and UCB PHARMA· ·:
`·3· ·GMBH· · · · · · · · · · · · ·: C. A. No.
`· · · · · · · · · · · · · · · · · : 1:15-cv-000079(GMS)
`·4· · · · · · · · Plaintiffs,· · ·: Consolidated
`· · ·v.· · · · · · · · · · · · · ·:
`·5· · · · · · · · · · · · · · · · :
`· · ·MYLAN PHARMACEUTICALS INC., :
`·6· · · · · · · · · · · · · · · · :
`· · · · · · · · · Defendant.· · · :
`·7· ·- - - - - - - - - - - - - - -x
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`·8
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`·9· · · · · · · · · · ***CONFIDENTIAL***
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`10
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`11· · · · · · ·Oral deposition of LEONARD J. CHYALL,
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`12· ·Ph.D. taken pursuant to notice, held on Tuesday,
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`13· ·August 23, 2016, at the office of Kilpatrick
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`14· ·Townsend & Stockton, 1114 Avenue of the Americas,
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`15· ·New York, New York, commencing at 9:01 a.m. before
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`16· ·Jamie I. Moskowitz, RPR, CRR, a Registered
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`17· ·Professional Reporter and Notary Public.
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`18· · · · · · · · · · · ·*· ·*· ·*
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 1
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 76
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`·1· ·going to start with some subset of physiologically
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`·2· ·compatible organic or inorganic acids, right?
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`·3· · · · · · · · ·MS. MEDINA:· Objection.
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`·4· · · · · · · · ·THE WITNESS:· If the salt screen is
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`·5· · · · for a pharmaceutical application, yes.· The
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`·6· · · · screen should be limited to materials that are
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`·7· · · · generally regarded as safe.
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`·8· · · · · · · · ·The FDA has what's called a GRAS list,
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`·9· · · · G-R-A-S, and this is a very large list of all
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`10· · · · the chemicals, food additives included, that
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`11· · · · are safe for human consumption.
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`12· ·BY MR. HOLLOWAY:
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`13· · · · Q· · · · How big is the GRAS list?
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`14· · · · A· · · · It's quite extensive.
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`15· · · · Q· · · · Do you have an idea of what the
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`16· ·numbers is?
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`17· · · · A· · · · Thousands.
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`18· · · · Q· · · · Realistically, the two people working
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`19· ·on this problem of finding an acceptable
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`20· ·pharmaceutical salt of the same active base, they're
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`21· ·not going to start by testing thousands of acids,
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`22· ·correct?
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`23· · · · A· · · · Not thousands, no.
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`24· · · · Q· · · · Instead our two people of ordinary
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`25· ·skill in the art, who are working on the same
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 2
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
`
`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 77
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`·1· ·problem but in different places, are probably going
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`·2· ·to choose -- each of them are going to choose an
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`·3· ·even smaller subset of acids in an attempt to find
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`·4· ·an acceptable pharmaceutical salt, correct?
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`·5· · · · · · · · ·MS. MEDINA:· Objection.
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`·6· · · · · · · · ·THE WITNESS:· The list of thousands
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`·7· · · · that are conceivable would be whittled down
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`·8· · · · initially to a manageable amount.· And what one
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`·9· · · · chemist considers manageable versus another is
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`10· · · · going to vary.
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`11· ·BY MR. HOLLOWAY:
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`12· · · · Q· · · · And part of what they consider
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`13· ·manageable could in part be dictated by their
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`14· ·available resources that that chemist has at
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`15· ·their -- at their ready, right?
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`16· · · · A· · · · Yes.
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`17· · · · Q· · · · So if I had a team of 15 people
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`18· ·working on the problem, and my other hypothetical
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`19· ·person not at SSCI only has three available people
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`20· ·to work on it, my set might be larger than their set
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`21· ·of acids to try, correct?
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`22· · · · · · · · ·MS. MEDINA:· Objection.
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`23· · · · · · · · ·THE WITNESS:· I don't know.
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`24· ·BY MR. HOLLOWAY:
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`25· · · · Q· · · · Would you agree that my set -- even if
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
`
`800-333-2082800-333-2082
`
`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
`
`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 3
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
`
`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 98
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`·1· ·the amount of active that can be dosed to a patient?
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`·2· · · · · · · · ·MS. MEDINA:· Objection.
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`·3· · · · · · · · ·THE WITNESS:· I haven't considered
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`·4· · · · that issue either.
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`·5· ·BY MR. HOLLOWAY:
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`·6· · · · Q· · · · Would you agree with me that a viable
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`·7· ·pharmaceutical candidate must be highly crystalline?
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`·8· · · · A· · · · No.
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`·9· · · · Q· · · · Would you agree with me that when
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`10· ·we're talking about crystalline salts, it's
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`11· ·absolutely necessary to have stable salts which are
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`12· ·chemically and thermally stable on the shelf?
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`13· · · · · · · · ·MS. MEDINA:· Objection to form.
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`14· · · · · · · · ·THE WITNESS:· It depends on what
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`15· · · · context we're talking about crystalline salts.
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`16· ·BY MR. HOLLOWAY:
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`17· · · · Q· · · · How does it depend on the context when
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`18· ·we're talking about crystalline salts?
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`19· · · · A· · · · Because precisely what surrounds the
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`20· ·issues will determine whether that statement is true
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`21· ·or not.
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`22· · · · Q· · · · Is it safe to say that based on your
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`23· ·experience, and view of salt screening, that the
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`24· ·identification and selection of an acid residue for
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`25· ·a known active base could never be obvious?
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`
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
`
`800-333-2082800-333-2082
`
`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 4
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
`
`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 99
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`·1· · · · · · · · ·MS. MEDINA:· Objection.
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`·2· · · · · · · · ·THE WITNESS:· The outcome of that
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`·3· · · · acid-based reaction can't be predicted in
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`·4· · · · advance.· The chemistry in solution can be
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`·5· · · · predictable, but whether or not the solid could
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`·6· · · · be isolated as a solid even, one doesn't know
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`·7· · · · that in advance.
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`·8· · · · · · · · ·MR. HOLLOWAY:· We have been going over
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`·9· · · · an hour, so if you want to take a break, let me
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`10· · · · know.
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`11· · · · · · · · ·THE WITNESS:· I'm fine.
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`12· ·BY MR. HOLLOWAY:
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`13· · · · Q· · · · In your rebuttal report, if you will
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`14· ·go to Paragraph 32, please.
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`15· · · · A· · · · Yes.
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`16· · · · Q· · · · And it references Dr. Janero's report.
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`17· ·And the preceding paragraph is talking about the
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`18· ·Gould reference in a section that's talking about
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`19· ·the Berge reference.
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`20· · · · · · · · ·THE WITNESS:· If you don't mind, could
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`21· · · · you withdraw the question?· I'd like to take a
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`22· · · · quick break, and then you can pick up your
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`23· · · · question later or I can answer the question
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`24· · · · that you have pending.
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`25· · · · · · · · ·MR. HOLLOWAY:· I haven't asked the
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
`
`800-333-2082800-333-2082
`
`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
`
`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 5
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
`
`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 117
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`·1· ·ordinary skill in the art would have been good at
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`·2· ·designing an active compound but have no experience
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`·3· ·in salt selection?
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`·4· · · · · · · · ·MS. MEDINA:· Objection.
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`·5· · · · · · · · ·THE WITNESS:· That's not what I said.
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`·6· ·BY MR. HOLLOWAY:
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`·7· · · · Q· · · · Well, how did I get that wrong?
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`·8· · · · A· · · · Because what I talked about is that
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`·9· ·that hypothetical person would be approaching salt
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`10· ·screening and salt selection from a basis that's not
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`11· ·as advanced as an expert such as myself would, and
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`12· ·their approach would differ than mine.
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`13· · · · Q· · · · So would they have had any experience
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`14· ·in trying salt screening to be a person of ordinary
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`15· ·skill in the art in the time of this invention?
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`16· · · · A· · · · They could have, but I don't believe
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`17· ·it's necessary that they do.
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`18· · · · Q· · · · Okay.· And isn't it fair to say that
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`19· ·if you -- if it's your opinion that a person of
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`20· ·ordinary skill in the art, at issue in this
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`21· ·invention, had no experience in salt screening.
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`22· · · · · · · · ·Wouldn't you say, okay, the likelihood
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`23· ·of this person finding an acceptable salt is just a
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`24· ·shot in the dark?
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`25· · · · A· · · · The skilled person has access to prior
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`
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
`
`800-333-2082800-333-2082
`
`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
`
`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 6
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
`
`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 118
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`·1· ·art.· So at the time of this invention, the skilled
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`·2· ·person certainly would have been aware of Berge and
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`·3· ·Gould.· It's my understanding from the attorneys
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`·4· ·that the skilled person is aware of all relevant
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`·5· ·prior art, so I consider Berge and Gould to be part
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`·6· ·of that.
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`·7· · · · · · · · ·It would be somewhere greater than a
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`·8· ·shot in the dark, but certainly less than the expert
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`·9· ·lab at SSCI among other experts in the area.
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`10· · · · Q· · · · So your position, as you have said
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`11· ·several times, is that you're beyond the skill of an
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`12· ·ordinary skill artist and you are an expert in this
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`13· ·field.· As an expert in this field, do you possess
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`14· ·the capability to predict for a given pharmaceutical
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`15· ·base whether an acid residue will yield an
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`16· ·acceptable product?
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`17· · · · A· · · · No.
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`18· · · · · · · · ·MR. HOLLOWAY:· Pass the witness.
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`19· · · · · · · · ·MS. MEDINA:· No questions.
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`20· · · · · · · · (Whereupon, the deposition concluded
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`21· · · · at 12:28 p.m.)
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075 - Page 7
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